GMP Quality Control/Quality Assurance
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Requirements for Drug Good Manufacturing Practices (GMPs) are regulated by Part C, Division 2 of the Canadian Food and Drug Regulations. The Canadian Drug GMPs note specific requirements involved in getting the product through to the final consumer:
DSA Consultants supplies both short and long term consulting services to help our clients comply with Canadian GMP requirements. A DSA GMP Consultant can provide project-related assistance for short-term projects due to staff shortages, excess workloads or to add technical expertise to a project. A DSA GMP Consultant can also provide services as your full-time, part-time, or permanent part-time "Head of Quality Control". Whether a DSA GMP Consultant acts as your contract Quality Control/Quality Assurance department or supplements your in-house departments, we can assist you with the following compliance activities:
To find out more about Canadian GMPs and how they impact marketing of a therapeutic product, please request a copy of our white paper. For more information on DSA Consultants and our GMP consulting services, please contact us to request an estimate. Product ReleasesWhere DSA acts as your Quality Control Department, we hold the responsibility for releasing drug & biologic products into the Canadian marketplace. We review lot specific production documents to ensure compliance with the master production document. Where required by GMPs, we arrange for confirmatory analytical testing. If all documents are satisfactory, we promptly release products for sale in Canada. Wherever possible, we recommend reduced testing programs and use of "unique identifier" testing exemptions which allow our clients to save on costly lab testing costs and help us to expediently release products into the marketplace. Let us review your product line-up to determine if there are any testing efficiencies that are not being realized. Contact us to find our more about our GMP Consulting Services and how we can assist with your product release needs. Stability ProgramsA DSA Quality Consultant can help you set up accelerated and room temperature studies. If needed, our Quality Consultants can draft protocols for you to implement within your labs. Alternatively, we can implement and manage your stability programs for you. An experienced Quality Consultant can also provide valuable input on the design and format of your data templates to ensure that information required by Health Canada is recorded for review. Our Quality Consultants review your stability protocols to ensure your compliance with Canadian GMPs and/or ICH guidelines and your marketing authorization. We then review your stability data to ensure compliance with your protocol. Our Quality Consultants can provide valuable assistance with investigation of OOS (out-of-specification) and OOT (out-of-trend) results. Where needed, our Regulatory Consultants can prepare filings to Health Canada to support changes to the approved shelf life or stability commitments. DSA Consultants provides a full range of services for drafting protocols or monitoring programs for challenge studies such as freeze/thaw studies which will generate excursion data for transportation and shipping conditions. Contact us to find out more information on our GMP Consulting services and how DSA Consultants can be of assistance in helping you develop or manage your stability programs.
Site Reference FilesHealth Canada allows companies to prepare and submit Site Reference Files for review. The purpose of the Site Reference File is to provide an overview of the firm’s compliance with GMP. There are several sections of the Site Reference file which will provide an overview of the premises of the establishment, the activities carried out, the personnel who run the organization and administer Good Manufacturing Practices (GMP), the equipment used, and the specifications in place to ensure adherence to quality. Site Reference Files should facilitate Drug GMP Inspections by allowing the Inspector to familiarize themselves with company operations prior to inspection, allowing the actual inspections to take less time as the Inspector only needs to verify information. DSA can prepare Site Reference Files for submission to Health Canada. We can also review your existing Site Reference Files and audit your organization to determine what updates need to be filed with Health Canada. |
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